Thursday, April 2, 2009

CAN DOCS "WEAN" THEMSELVES????

Docs Urged to Cut Corporate Ties; PhRMA Warns of Invasion by the "Very Junior People"

In an article in today's NYT, the folks at the Institute for Medicine as a Profession are again advocating for definitive separation between medicine from the medical industries in key areas. This is not the first time the call has gone out. A JAMA article in 2006 was perhaps more radical. But the warnings go on. (And the JAMA article is itself linked in the NYT piece). Here the emphasis on industry's influence over practice guidelines (e.g., LDL triggers for statin use, etc.)

http://www.nytimes.com/2009/04/02/health/policy/02journal.html?_r=1&emc=tnt&tntemail1=y

The response from PhRMA is worth including as the NYT did. It reads:

'Marjorie Powell, senior assistant general counsel for Pharmaceutical Research and Manufacturers of America, a drug industry trade group, said the proposals could deprive the medical community of the expertise of some of its most experienced doctors, who are often deeply involved in industry-financed research.

“The vast majority of the research is funded by pharmaceutical companies,” Ms. Powell said. Important decisions regarding practice guidelines might be made, she said, by “very junior people who have no experience.”'

If we are to believe PhRMA, this would make most of those who are (supposed to) serve on FDA Advisory Committees "very junior people who have no experience." So also the editors of JAMA and NEJM who have generally supported these initiatives.

These "experience-challenged" people may be compared with the docs CROs hire to carry out clinical trials. True, they usually don't write practice doctrines. They are usually bought--excuse me--brought in for a subsidiary task. Perhaps, what is suitable for "very junior people."

5 comments:

  1. Is a "senior assistant general counsel" a senior person? Or a junior person?

    ReplyDelete
  2. Re: Can docs wean themselves?

    In May 2008 a state formulary committee denied a request to add Seroquel XR to the state's formulary. Here is a passage from the meeting:

    “The available literature shows similar efficacy and tolerability profiles between quetiapine XR and quetiapine IR, except for the Moller study which found that noninferiority was not shown and the switch was not successful for the MITT [modified intent-to-treat] population studied in this trial (noninferiority was shown for the per-protocol population). Studies such as BOLDER I and BOLDER II have administered quetiapine IR once daily at bedtime with good tolerability after a short initial titration period (300 mg by day 4). Quetiapine IR offers the advantage of greater dosing flexibility in special patient populations. Currently, quetiapine XR and quetiapine IR are priced the same. Looking at the available peer-reviewed literature, pricing information and potential for generic quetiapine in the future, there does not appear to be a compelling reason to add quetiapine XR to the drug formulary at this time.”

    Retrieved April 5, 2009, from
    http://www.dshs.state.tx.us/mhprograms/pdf/EFC_Minutes_05_16_08.pdf

    An academic psychiatrist who helped develop the state's medication algorithms for depression appears on a draft agenda under "Industry Presentation" for an upcoming FDA committee meeting to discuss the safety and efficacy of Seroquel XR for depression and anxiety. The draft agenda is posted here:
    http://www.fda.gov/ohrms/dockets/ac/09/agenda/2009-4424a2-FDA-draft.pdf

    ReplyDelete
  3. Brown University medical students fight back. Click on the Editorial comment link above.

    ReplyDelete
  4. Pharma policies deserve failing grade...

    The link in the previous post is broken. Try this one:

    http://media.collegepublisher.com/media/paper472/documents/1br6c5ho.pdf

    ReplyDelete
  5. Longtime chair of psychiatry resigns...

    This is an excellent article as well.

    ReplyDelete

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